The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
474
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
Percent Change From Baseline in Body Weight at Week 26
Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
Time frame: Baseline, Week 26
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.
Time frame: Up to Week 30
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
Number of participants with \>= 5% body weight loss from baseline to Week 26 were reported.
Time frame: Week 26
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
Number of participants with \>= 10 % body weight loss from baseline to Week 26 were reported.
Time frame: Week 26
Change From Baseline in Body Weight at Week 26
Change from baseline in body weight at Week 26 was reported.
Time frame: Baseline, Week 26
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Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
Participants will receive matching placebo SC once-weekly until Week 26.
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Care Partners Clinical Research
Jacksonville, Florida, United States
Advanced Clinical Research
Boise, Idaho, United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, United States
L-Marc Research Center
Louisville, Kentucky, United States
Milford Emergency Associates, Inc.
Marlborough, Massachusetts, United States
Central New York Clinical Research
Manlius, New York, United States
Weill Cornell Medicine
New York, New York, United States
Rapid Medical Research
Cleveland, Ohio, United States
...and 41 more locations